To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID
Status:
Recruiting
Trial end date:
2024-11-30
Target enrollment:
Participant gender:
Summary
This study is an interventional, randomized, multinational, multicenter, double-blind, phase
2 study with a follow-up period of circa 12 months.
The intension of this clinical trial is to investigate the long-term sequelae (named Long
COVID syndrome; post COVID or PASC) of an infection with Corona Virus Type 2 that has
resulted in a condition known as Severe Acute Respiratory Syndrome Corona Virus Type 2
(SARS-CoV-2).
The purpose of this study is to evaluate the efficacy and safety of BC 007 as a treatment for
long-lasting COVID-symptoms in patients who were neither intubated nor supported with
extracorporeal blood oxygenation (ECMO) during their acute COVID-19 infection.
The study drug acts by neutralizing functional autoantibodies directed against G-protein
coupled receptors (GPCRs).
Neutralization of the autoantibodies is expected to induce a beneficial effect on symptoms
typically seen in patients with long COVID syndrome.
Functional autoantibodies are proteins belonging to the class of G-type immunoglobulins that
can be synthesized by activation of the immune system and can induce various pathogenic
activities by binding to one of the extracellular loops of G-proteins (GPCR-AAB).
The study consists of a screening phase of up to 21 days, treatment (two administrations by
intravenous infusion at two-week intervals either with the study drug (BC 007) or with
placebo (NaCl 0.9%), with an initial follow-up period of 15 days after each administration
and an extended follow-up period of 330 days.
Patients are required to visit the study center for follow-up visits at specified intervals.
For the entire study duration of 381 days from screening to the end of the study, 11 site
visits are planned.